Prospective, Randomized Comparison of Fellow Eyes Undergoing SBK with Use of Brimonidine 0.025%, Naphazoline 0.025% with Pheniramine 0.3%, or Artificial Tears

Daniel S. Durrie M.D.

Joel D. Hunter M.D.Durrie Vision

Overland Park, KS

• Presently Dr. Durrie is a clinical investigator for:– Alcon– Allergan– AMO– Bausch and Lomb– IntraLase– Refractec– Acufocus– WaveTec– Avedro– Encore Vision– LenSx

• Dr. Hunter has no financial relationships to disclose.

– Wavefront Science– NeuroVision– High Performance Optics– OcuSense– QuestVision– Visiometrics– Tracey Technologies– High Performance Optics– Topcon– Ocular Optics

Dr. Durrie Potential Conflicts of Interest

Purpose

• To compare injection, subconjunctival hemorrhage, patient comfort, and adverse events during and after SBK for each of the three drops.

Background

• Brimonidine is a selective α-2 adrenergic agonist that causes vasoconstriction when administered topically1,2

– Recently shown to increase chance of flap slip after LASIK,3 and to decrease chance of flap slip after LASIK4

• Naphazoline is a non-selective adrenergic agonist with greater α-1 than α-2 effect5

– Only study in literature addressing naphazoline with LASIK did not address complications6

Study Design

• This 1-hour and 1-day prospective, randomized clinical trial includes 180 consecutive patients (360 eyes) that underwent Sub-Bowman Keratomileusis (SBK) for the correction of myopia or hyperopia with or without astigmatism

• All procedures were performed with the IntraLase FS Laser and Wavelight Allegretto

Study Design

• Patients were randomized into three groups receiving differing drops in each eye pre-operatively– Alphagan P 0.025% in one eye and Naphcon-A

in the contralateral eye – Alphagan P 0.025% in one eye and Systane

Ultra in the contralateral eye– Naphcon-A in one eye and Systane Ultra in the

contralateral eye

Study Design

• Patients filled out questionnaires one hour and one day post-operatively to compare pain and irritation for each eye

• Patients were also examined one hour and one day post-operatively for uncorrected visual acuity, injection, subconjunctival hemorrhage, and debris under the flap

Alphagan 0.025% vs. Systane Ultra

Intra-operative photos of same patient with Alphagan 0.025% OD (R) and Systane Ultra OS (L)

Current Findings

• 100 of 180 patients enrolled, with expected completion of enrollment May 2010

• Single incidence of bilateral flap slip in patient randomized to Naphcon vs. Brimonidine 0.025%

Reports to Come

• To be presented at AAO 2010 with complete follow up on all 180 patients

• One hour and one day patient questionnaires comparing preference between eyes

• One hour, one day, one month, and three month comparisons of uncorrected and best corrected visual acuity, as well as manifest refraction vs. pre-operative target refraction

References

1. Nielsen H, Thom SM, Hughes AD, Martin GN, Mulvany MJ, Sever PS. Postjunctional alpha 2-adrenoceptors mediate vasoconstriction in human subcutaneous resistance vessels. Br J Pharmacol. 1989 Jul;97(3):829-34.

2. McGrath JC. Evidence for more than one type of post-junctional alpha-adrenoceptor. Biochem Pharmacol. 1982 Feb 15;31(4):467-84.

3. Nowroozzadeh MH. Early flap dislocation with perioperative brimonidine use in laser in situ keratomileusis. J Cataract Refract Surg. 2010 Feb; 36(2):368.

4. Rodríguez-Galietero A, Martínez JV, Del Buey A, Bescós JA. Use of brimonidine before LASIK with femtosecond laser-created flaps for the correction of myopia: a contralateral eye study. J Refract Surg. 2010 Jan;26(1):28-32

5. Ogidigben MJ, Chu TC, Potter DE. Naphazoline-induced suppression of aqueous humor pressure and flow: involvement of central and peripheral alpha(2)/I(1) receptors. Exp Eye Res. 2001 Mar;72(3):331-9.

6. Gu B, Dou X, Sima J, Peng N. The application of naphcon eye drops during Lasik surgery. Yan Ke Xue Bao. 2004 Dec;20(4):206-7.